China's first independently developed mRNA vaccine officially approved for market launch

2026-09-10 22:03

On September 10, 2026, Yunnan Watson Biotechnology Co., Ltd. (Watson Biotechnology) announced that "the wholly-owned subsidiary Yuxi Watson Biotechnology Co., Ltd. (hereinafter referred to as" Yuxi Watson ") received the" novel coronavirus mRNA vaccine "and" Drug Registration Certificate "(certificate number: 2026S03320) approved and issued by the State Drug Administration on September 10, 2026. The approval date is September 8th, 2026. ”

This is China's first mRNA vaccine developed and approved for market based on mRNA platform technology strategy iteration.

Since 2020, this research and development project has been listed as a key supported project by the Ministry of Science and Technology, the National Development and Reform Commission, and the Yunnan Provincial Department of Science and Technology.

This new vaccine is jointly developed by Professor Lin Jinzhong's team from Fudan University, Shanghai Lanque Biotechnology, Guangzhou Laboratory, and Watson Biosciences for mRNA vaccine technology transformation supported by Fudan University.

MRNA vaccines are one of the most advanced vaccine preparation routes internationally, with advantages such as efficient immune activation and rapid iteration.

The full name of mRNA is Messenger RNA, which can be understood as a "blueprint" for the production of proteins by cells. The genetic information it carries can be read by the cell's protein synthesis system and used to synthesize specific proteins. Taking vaccines as an example, traditional vaccines usually directly provide antigens or use viral vectors to allow human cells to express antigens; MRNA vaccines deliver genetic information encoding antigens into cells, temporarily turning human cells into antigen production factories. Traditional vaccines are more like "sending fish", while mRNA vaccines are more like "teaching people how to fish" - by providing a piece of designable genetic information, allowing cells to produce target antigens according to instructions, thereby activating the immune system and establishing immune memory. This "programmability" is also an important foundation for mRNA technology to quickly design and iterate for different pathogens and diseases.

In 2023, Katalin Carrico and Drew Weissman were awarded the Nobel Prize in Physiology or Medicine for solving the core problem of mRNA drug development.

China's 15th Five Year Plan positions biopharmaceuticals as a strategic emerging industry and lists nucleic acid drugs as a key technological breakthrough direction, with mRNA technology being the core of nucleic acid drugs. From a global perspective, the mRNA industry is also shifting from being "pandemic driven" to "platform driven".

The Watson BioNTech announcement states: "Currently, mRNA technology is being applied globally in the forefront of innovative research and application in the field of biomedicine. Since 2020, the company has continuously increased its R&D investment in mRNA technology and established a leading mRNA technology and industrialization platform in China. On the one hand, it provides a new technological route for the research and development of new preventive vaccines; At the same time, it has also laid a solid foundation for promoting tumor vaccines, protein replacement drugs, In Vivo CAR-T, and other therapeutic fields. The respiratory syncytial virus mRNA vaccine and freeze-dried herpes zoster mRNA vaccine developed by the company based on mRNA technology platform have obtained clinical approval, while other therapeutic mRNA drugs are in the preclinical research stage. The respiratory syncytial virus mRNA vaccine and freeze-dried herpes zoster mRNA vaccine submitted by Watson Biotech have obtained clinical approval in 2025 and are about to enter phase I clinical research; In the more cutting-edge field of tumor treatment, the company is actively laying out personalized/universal new antigen tumor mRNA vaccines, and exploring mRNA based autologous cell therapy products and protein replacement therapies. ”

From the perspective of industrial policy environment, since 2025, the Drug Evaluation Center of the National Medical Products Administration has successively issued technical guidance principles for non clinical, pharmaceutical, and clinical trials of mRNA vaccines for prevention, providing institutional guarantees for the development of the industry.